Director, Regulatory Affairs Strategy - Basking Ridge , New Jersey, United States, 07920
Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.
This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe. This position acts as point of contact for interactions with Health Authorities (HA) and global cross-functional team members and may lead team(s) when conducting FDA and/or EMA interactions. This position fosters a global view on cross-functional teams, and mentors and provides guidance to junior RA representatives. This position provides regulatory advice on internal or partnered development assets. Additionally, this position interacts with RA team members both regionally and globally, cross-functional team members, FDA Project Managers and/or Reviewers, and may interact directly or indirectly with ex-US Health Authorities. This position works often with moderate level of ambiguity and complex problems, and focuses on developing and coordinating the implementation of a global regulatory strategy. This position works with a high level of independence and autonomy, has a high degree of latitude to manage workload, takes initiative and defines direction without needing guidance. This position acts as a coach in a matrix team environment, and motivates self and others to complete projects on time.
1. Regulatory Knowledge: Maintains a high level of regulatory knowledge and provides regulatory advice.
2. Agency Interactions: Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor.
3. Dossier Submissions: Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions.
4. Registration Strategy: Leads the formulation of registration strategies for products/projects. Ensures US and/or EU registration strategies are designed and captured in the Global Regulatory Affairs Strategy Plan and ensures implementation of the strategy. Ensures registration strategies adhere to corporate objectives.
5. Team Interactions: Provides regulatory affairs representation on project teams; may lead regulatory sub-teams. May act as single point of RA contact on cross-functional teams; fosters a global view as a member of the development team.
6. People Management: Mentors and provides guidance to junior RA representatives in a matrix environment.
Education and Experience
- Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.) with preference for M.D. and Ph.D. JD with appropriate regulatory experience would be considered.
- Experience in the pharmaceutical industry (8-10 years), including direct oncology regulatory affairs with the FDA preferred.
- Experience with ex-US regulatory authorities would be a plus
Director, Regulatory Affairs Strategy
R&D Regulatory Affairs